A clinical trial to study effect of a drug metformin in slowing progression of autosomal dominant polycystic kidney disease

Metformin vs standard of care in slowing progression of autosomal polycystic kidney disease and correlation with total kidney volume and plasma copeptin levels

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042904

Enrollment

Registered

2022-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q612- Polycystic kidney, adult type

Interventions

Intervention1: Metformin: Maximum dose - 2 grams/day Duration - 6 months Control Intervention1: Standard of care: Fluid intake more than 3L/day , Blood pressure control. Duration - 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of ADPKD based on updated ravine criteria 2.eGFR >= 45 ml/min/1.73 m2 3.Controlled blood pressure < 130/80 on a stable regimen of antihypertensive drugs

Exclusion criteria

Exclusion criteria: 1. ADPKD patients who fulfill the criteria of likely rapid disease progression at baseline ( kidney length >=16.5 cm, as assessed by ultrasound (or MRI) in patients younger than 50 years , PRO-PKD score > 6, Mayo class 1C, D, E) 2. Diabetes mellitus (as defined by American Diabetes Association consensus criteria) 3. Intolerance to metformin 4. Uncontrolled hypertension 5. Pregnancy / Lactation 6. Systemic diseases which contribute to renal disease other than hypertension 7. Acute or chronic disease causing tissue hypoxia (e.g.: myocardial failure, severe arrhythmia, myocardial infarction, respiratory failure, liver failure, alcohol acute intoxication, alcoholism, dehydration). 8. Systemic infection 9. Essential drugs with drug interactions with metformin including nifedipine and furosemide

Design outcomes

Primary

Measure	Time frame
To study the percent change from baseline in height adjusted total kidney volume as measured by CT-scan at 6 months between Metformin and Standard of care groupTimepoint: 6 months	—

Secondary

Measure	Time frame
To study metformin medication adherence and safetyTimepoint: 6 months;To study the association of baseline copeptin levels with disease progression and whether treatment induced changes in copeptin levels are associated with metformin treatment efficacyTimepoint: 6 months;To study the difference between blood pressures and 24 hour urine protein excretion in metformin and standard of care armTimepoint: 6 months;To study the difference between groups in annualized slope of eGFR (CKD-EPI)Timepoint: 6 months	—

Measure

Time frame

To study metformin medication adherence and safetyTimepoint: 6 months;To study the association of baseline copeptin levels with disease progression and whether treatment induced changes in copeptin levels are associated with metformin treatment efficacyTimepoint: 6 months;To study the difference between blood pressures and 24 hour urine protein excretion in metformin and standard of care armTimepoint: 6 months;To study the difference between groups in annualized slope of eGFR (CKD-EPI)Timepoint: 6 months

—

Countries

India

Contacts

Public ContactJasmine Sethi

Postgraduate Institute of Medical Education and Research

jasmine227021@gmail.com9855422270

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026